Non-invasive Pain Monitoring in Post-operative Patients (ANSPEC)

February 5, 2019 updated by: University Ghent

Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients

During the current pain monitoring system the patient is awake and he/she is asked to give a numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop later a method/algorithm for automatic evaluation of pain (objective measurement of pain). The measurement is done using standard ECG electrodes placed in the hand palm of the patient. The patient feels nothing during the observations, perhaps irritation of skin may occur as result of long time measurement. As a comparison to the investigators prototype, a commercial device is also used in (randomly selected) patients, i.e. the MedStorm device.

The study will try to answer the following questions:

  • Are the measurements with the ANSPEC-PRO correlated with the NRS values?
  • What is the (mathematical) relationship between the measured values and the NRS?
  • Is there difference between the two devices in measuring pain levels? And what is this difference if pain alleviation medication is given to the patient?
  • A number of 26 patients is envisaged for this study, equally distributed to be evaluated with the two devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Clara Ionescu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients planned for operation, between 18 and 70 years old, not pregnant, not in chronic pain and not taken anticonvulsants or antidepressants.

Description

Inclusion Criteria:

  • patients postoperative of a painfull operation
  • between 18 and70 years old

Exclusion Criteria:

  • day surgery patients
  • chronic pain patients
  • taken medication : anticonvulsants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ANSPEC-PRO
These patients are selected (after randomized selection) to be monitored non-invasively for pain level via prototype ANSPEC-PRO - correlated to a NRS number given by the awake patient in PACU/ICU.
Device: ANSPEC-PRO
Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
Other Names:
  • MEDSTORM
MEDSTORM
These patients are selected (after randomized selection) to be monitored non-invasively for pain level via MEDSTORM - correlated to a NRS number given by the awake patient in PACU/ICU.
Device: ANSPEC-PRO
Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
Other Names:
  • MEDSTORM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.
Time Frame: 140 minutes each patient
Pain monitoring of awake patients which are standardly treated for pain using the numerical rating scale. The main outcome is a correlation between ANSPEC-PRO device and the numerical rating scale.
140 minutes each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

June 26, 2018

Study Completion (Actual)

June 26, 2018

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/1517

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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